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The ImagenMD™ with ImagenQ™ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.

ImagenMD™ with ImagenQ™ is a Windows software application which allows physicians and healthcare professionals to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The user can perform quality assessments, automatically and manually select myocardial boundaries and alignment, and visualize the results of quantitative perfusion calculations. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

This submission, K080770, describes the ImagenMD™ with ImagenQ™ system, a Windows software application designed to inspect, quantitatively and automatically perform calculations on myocardial perfusion PET images. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, the provided text does not contain information regarding
acceptance criteria, a specific study proving the device meets said criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or details on how ground truth was established for training.

The submission primarily states that the device is "equivalent to the predicates" based on "testing and comparison of technological characteristics and intended uses." This implies that the device's functionality and output are comparable to existing, legally marketed devices, rather than establishing numerical performance metrics against pre-defined acceptance criteria.

Based on the provided text, the following information can be extracted/deduced:

1. A table of acceptance criteria and the reported device performance:

   • Not provided. The submission asserts substantial equivalence to predicate devices without detailing specific performance metrics or acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The submission does not describe a clinical performance study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No test set or ground truth establishment process is described in the provided document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not provided. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not provided. The device is described as assisting qualified healthcare providers, implying it's not a standalone diagnostic tool, and no standalone performance study is detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not provided. No information on ground truth is available.

8. The sample size for the training set:

   • Not provided. No information on a training set is available.

9. How the ground truth for the training set was established:

   • Not provided. No information on a training set or its ground truth establishment is available.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence by comparing technical characteristics and intended uses to existing predicate devices, rather than presenting a detailed performance study with quantifiable acceptance criteria.

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The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images from a remote location. The system allows the user to view quantify and process perfusion and gated SPECT images.

ImagenMD™ is a software application installed on laptop computers which allows physicians and healthcare professionals to view myocardial perfusion SPECT or PET images from their office, hospital or home. The system processes perfusion and gated SPECT performing quantitative data analysis. The user can select raw, short axis, transmission slice and gated short axis studies for the purpose of examining those images for abnormalities and artifacts. The system contains optional databases which quantify the extent and severity of myocardial defects. Also included is an application for the display and analysis of gated short axis blood pool SPECT datasets. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The provided document does not contain information regarding a specific study with acceptance criteria and reported device performance. It is a 510(k) summary for the ImagenMD™ system, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed clinical trial results or performance metrics against defined acceptance criteria.

The document describes the device, its indications for use, and compares its technical characteristics to predicate devices (AutoQUANT, SeeMor, QBS). It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone (algorithm only) performance study details.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission for premarket notification (510(k)), which typically demonstrates equivalence to existing legally marketed devices rather than providing the detailed clinical study data often found in PMA submissions or peer-reviewed publications.

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